Агаева Р.А., Данилов Н.М., Щелкова Г.В. и др. Новые возможности ренальной денервации. Терапевтический архив. 2020; 92 (6): 84–88.
DOI: 10.26442/00403660.2020.06.000588
Агаева Р.А., Данилов Н.М., Щелкова Г.В. и др. Новые возможности ренальной денервации. Терапевтический архив. 2020; 92 (6): 84–88.
DOI: 10.26442/00403660.2020.06.000588
Около 10 лет назад радиочастотная денервация почечных артерий представлена как метод малоинвазивного лечения резистентной артериальной гипертонии. Первые исследования продемонстрировали эффективность данной процедуры, что привело к растущему интересу в этой области и быстрому развитию данного метода. Тем не менее результаты первого рандомизированного исследования SYMPLICITY HTN-3 поставили под сомнение роль радиочастотной денервации в лечении резистентной артериальной гипертонии. Данный факт привел к снижению класса рекомендации и уровню доказательности в клинических рекомендациях Европейского общества кардиологов и Европейского общества по гипертонии в 2018 г. Сегодня в медицинском сообществе активно обсуждают результаты недавно опубликованных исследований, таких как SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, RADIANCE-HTN SOLO и RADIOSOUND-HTN.
Radiofrequency renal artery denervation (RND) was introduced as a method of interventional treatment of resistant hypertension almost ten years ago. The first studies demonstrated the effectiveness of this procedure. This has led to growing interest in this area and the rapid development of the method. However, the results of the first randomized trial of SYMPLICITY HTN-3 questioned the role of RND in the treatment of resistant hypertension, this fact conducted to the decrease in the recommendation class and level of evidence in the Guidelines of the European Society of Cardiology and the European Society of Hypertension in 2018. To date, the medical community is actively discussing the results of recently published trials such as SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, RADIANCE-HTN SOLO and RADIOSOUND-HTN.
1. Symplicity HTN-1 Investigators. Catheter-based renal sym- pathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011;57:911-7. doi: 10.1161/
HYPERTENSIONAHA.110.163014
2. Esler MD, Krum H, Sobotka PA, et al. Renal sympathetic dener- vation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-9.
doi: 10.1016/S0140-6736(10)62039-9
3. Bhatt DL, Kandzari DE, O'Neill WW, et al. A Controlled Trial of Renal Denervation for Resistant Hypertension. N Engl J Med. 2014;370(15):1393-401. doi: 10.1056/NEJMoa1402670
4. Kandzari DE, Bhatt DL, Brar S, et al. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015;36:219-27. doi: 10.1093/ eurheartj/ehu441
5. Flack JM, Bhatt DL, Kandzari DE, et al. An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and non-African Americans in the SYMPLICITY HTN-3 trial. J Am Soc Hypertens. 2015;9:769-79. doi: 10.1016/j.jash.2015.08.001
6. Mahfoud F, Bakris G, Bhatt DL, et al. Reduced blood pressure-low- ering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017;38:93-100. doi: 10.1093/eurheartj/ehw325
7. David E. Kandzari, Paul A. Sobotka Ready for a Marathon, Not a Sprint: Renal Denervation Therapy for Treatment-Resistant Hypertension. Journal of the American College of Cardiology. 2013;62(Issue 22):2131-3. doi: 10.1016/j.jacc.2013.07.047
8. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society
of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur Heart J. 2018;39(Issue 33):3021-104. doi: 10.1093/
eurheartj/ehy339
9. Schmieder RE, Redon J, Grassi G, et al. ESH position paper: renal denervation – an interventional therapy of resistant hypertension. J Hypertens. 2012;30:837-41. doi: 10.1097/HJH.0b013e328352ce78
10. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017;390:2160-70. doi: 10.1016/ S0140-6736(17)32281-X
11. Kandzari DE, Kario K, Mahfoud F, et al. The SPYRAL HTN global clinical trial program: rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON MED) of antihypertensive medications. Am Heart J. 2015;171:82-91. doi: 10.1016/j.ahj.2015.08.021
12. Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018;6736:1-10. doi: 10. 1016/S0140-6736(18)30951-6
13. Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hyper- tension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018;6736:1-11. doi: 10.1016/S0140-6736(18)31082-1
14. Azizi M, Schmieder RE, Mahfoud F, et al. Six-month results of treatment-blinded medication titra- tion for hypertension control following randomization to endovascular ultrasound renal denervation or a sham procedure in the RADIANCE-HTN SOLO trial. Circulation. 2019. doi: 10.1161/CIRCULATIONAHA.119.040451
15. Kądziela J, Warchoł-Celińska E, Prejbisz A, et al. Renal denervation – can we press the "ON" button again? Postepy Kardiol Interwencyjnej. 2018;14(4):321-7. doi: 10.5114/aic.2018.79863
16. Lauder L, Ewen S, Tzafriri AR, et al. Anatomical and procedural determinants of ambulatory blood pressure lowering following catheter-based renal denervation using radiofrequency. Cardiovasc Revasc Med. 2018;19:845-51. doi: 10.1016/j.carrev.2018.02.016
17. Lauder L, Ewen S, Tzafriri AR, et al. Renal artery anatomy assessed by quantita- tive analysis of selective renal angiography in 1,000 patients with hypertension. EuroIntervention. 2018;14:121-8. doi: 10. 4244/EIJ-D-18-00112
18. Sakakura K, Ladich E, Cheng Q, et al. Anatomic assessment of sympathetic peri-arterial renal nerves in man. J Am Coll Cardiol. 2014;64:635-43. doi: 10. 1016/j.jacc.2014.03.059
19. Sakaoka A, Terao H, Nakamura S, et al. Accurate depth of radiofrequency-induced lesions in renal sympathetic denervation based on a fine histological sectioning approach in a porcine model. Circ Cardiovasc Interv. 2018;11:e005779. doi: 10.1161/CIRCINTERVENTIONS.117. 005779
20. Mahfoud F, Tunev S, Ewen S, et al. Impact of lesion placement on efficacy and safety of catheter- based radiofrequency renal denervation.
J Am Coll Cardiol. 2015;66:1766-75. doi: 10.1016/j.jacc.2015.08.018
21. Mahfoud F, Lüscher TF. Renal denervation: symply trapped by complexity? Eur Heart J. 2015;36:199-202. doi: 10.1093/eurheartj/ehu450
22. Pekarskiy SE, Baev AE, Mordovin VF, et al. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension.
J Hypertens. 2017;35:369-75. doi: 10.1097/HJH.0000000000001160
23. Fengler K, Ewen S, Höllriegel R, et al. Blood pressure response to main renal artery and combined main renal artery plus branch renal denervation in patients with resistant hypertension. J Am Heart Assoc. 2017;6: e006196. doi: 10.1161/JAHA.117.006196
24. Fengler K, Rommel KP, Blazek S, et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654
25. Al Raisi SI, Pouliopoulos J, Swinnen J, et al. Renal Artery Denervation in Resistant Hypertension: The Good, The Bad and The Future. Heart Lung Circ. 2020 Jan;29(1):94-101. doi: 10.1016/j.hlc.2019.06.723
26. Lauder L, Wolf MA, Scholz SS, et al. Renal Denervation: Is It Ready for Prime Time? Curr Cardiol Rep. 2019 Jul 5;21(8):80. doi: 10.1007/s11886-019-1164-2
________________________________________________
1. Symplicity HTN-1 Investigators. Catheter-based renal sym- pathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011;57:911-7. doi: 10.1161/
HYPERTENSIONAHA.110.163014
2. Esler MD, Krum H, Sobotka PA, et al. Renal sympathetic dener- vation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010;376:1903-9.
doi: 10.1016/S0140-6736(10)62039-9
3. Bhatt DL, Kandzari DE, O'Neill WW, et al. A Controlled Trial of Renal Denervation for Resistant Hypertension. N Engl J Med. 2014;370(15):1393-401. doi: 10.1056/NEJMoa1402670
4. Kandzari DE, Bhatt DL, Brar S, et al. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur Heart J. 2015;36:219-27. doi: 10.1093/ eurheartj/ehu441
5. Flack JM, Bhatt DL, Kandzari DE, et al. An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and non-African Americans in the SYMPLICITY HTN-3 trial. J Am Soc Hypertens. 2015;9:769-79. doi: 10.1016/j.jash.2015.08.001
6. Mahfoud F, Bakris G, Bhatt DL, et al. Reduced blood pressure-low- ering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. 2017;38:93-100. doi: 10.1093/eurheartj/ehw325
7. David E. Kandzari, Paul A. Sobotka Ready for a Marathon, Not a Sprint: Renal Denervation Therapy for Treatment-Resistant Hypertension. Journal of the American College of Cardiology. 2013;62(Issue 22):2131-3. doi: 10.1016/j.jacc.2013.07.047
8. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society
of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur Heart J. 2018;39(Issue 33):3021-104. doi: 10.1093/
eurheartj/ehy339
9. Schmieder RE, Redon J, Grassi G, et al. ESH position paper: renal denervation – an interventional therapy of resistant hypertension. J Hypertens. 2012;30:837-41. doi: 10.1097/HJH.0b013e328352ce78
10. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017;390:2160-70. doi: 10.1016/ S0140-6736(17)32281-X
11. Kandzari DE, Kario K, Mahfoud F, et al. The SPYRAL HTN global clinical trial program: rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON MED) of antihypertensive medications. Am Heart J. 2015;171:82-91. doi: 10.1016/j.ahj.2015.08.021
12. Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018;6736:1-10. doi: 10. 1016/S0140-6736(18)30951-6
13. Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hyper- tension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018;6736:1-11. doi: 10.1016/S0140-6736(18)31082-1
14. Azizi M, Schmieder RE, Mahfoud F, et al. Six-month results of treatment-blinded medication titra- tion for hypertension control following randomization to endovascular ultrasound renal denervation or a sham procedure in the RADIANCE-HTN SOLO trial. Circulation. 2019. doi: 10.1161/CIRCULATIONAHA.119.040451
15. Kądziela J, Warchoł-Celińska E, Prejbisz A, et al. Renal denervation – can we press the "ON" button again? Postepy Kardiol Interwencyjnej. 2018;14(4):321-7. doi: 10.5114/aic.2018.79863
16. Lauder L, Ewen S, Tzafriri AR, et al. Anatomical and procedural determinants of ambulatory blood pressure lowering following catheter-based renal denervation using radiofrequency. Cardiovasc Revasc Med. 2018;19:845-51. doi: 10.1016/j.carrev.2018.02.016
17. Lauder L, Ewen S, Tzafriri AR, et al. Renal artery anatomy assessed by quantita- tive analysis of selective renal angiography in 1,000 patients with hypertension. EuroIntervention. 2018;14:121-8. doi: 10. 4244/EIJ-D-18-00112
18. Sakakura K, Ladich E, Cheng Q, et al. Anatomic assessment of sympathetic peri-arterial renal nerves in man. J Am Coll Cardiol. 2014;64:635-43. doi: 10. 1016/j.jacc.2014.03.059
19. Sakaoka A, Terao H, Nakamura S, et al. Accurate depth of radiofrequency-induced lesions in renal sympathetic denervation based on a fine histological sectioning approach in a porcine model. Circ Cardiovasc Interv. 2018;11:e005779. doi: 10.1161/CIRCINTERVENTIONS.117. 005779
20. Mahfoud F, Tunev S, Ewen S, et al. Impact of lesion placement on efficacy and safety of catheter- based radiofrequency renal denervation.
J Am Coll Cardiol. 2015;66:1766-75. doi: 10.1016/j.jacc.2015.08.018
21. Mahfoud F, Lüscher TF. Renal denervation: symply trapped by complexity? Eur Heart J. 2015;36:199-202. doi: 10.1093/eurheartj/ehu450
22. Pekarskiy SE, Baev AE, Mordovin VF, et al. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension.
J Hypertens. 2017;35:369-75. doi: 10.1097/HJH.0000000000001160
23. Fengler K, Ewen S, Höllriegel R, et al. Blood pressure response to main renal artery and combined main renal artery plus branch renal denervation in patients with resistant hypertension. J Am Heart Assoc. 2017;6: e006196. doi: 10.1161/JAHA.117.006196
24. Fengler K, Rommel KP, Blazek S, et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654
25. Al Raisi SI, Pouliopoulos J, Swinnen J, et al. Renal Artery Denervation in Resistant Hypertension: The Good, The Bad and The Future. Heart Lung Circ. 2020 Jan;29(1):94-101. doi: 10.1016/j.hlc.2019.06.723
26. Lauder L, Wolf MA, Scholz SS, et al. Renal Denervation: Is It Ready for Prime Time? Curr Cardiol Rep. 2019 Jul 5;21(8):80. doi: 10.1007/s11886-019-1164-2
Институт клинической кардиологии им. А.Л. Мясникова ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России, Москва, Россия